The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

PORTLAND, IN, UNITED STATES, January 28, 2025 /EINPresswire / -- The RNA based therapeutics has been explored as a promising treatment option for the diseases which are difficult to treat. Development ...

Sarepta Therapeutics' Elevidys for DMD shows revenue potential, with market cap justified at $11.4bn and potential for >50% gain by 2025. Learn more on SRPT stock here.

The agency labeled the action a Class I recall, its most serious designation. (Dubinsky, 1/14) Bloomberg: Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says Approvals for drugs from ...

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.

(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena. The Office of the Inspector General at the ...

It chose the other 14 at random. The office noted that both Aduhelm and Makena are no longer for sale. Exondys, sold by Sarepta Therapeutics, remains on the market, but its required trial to ...

The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...

Bank of America Securities analyst Tazeen Ahmad maintained a Buy rating on Sarepta Therapeutics (SRPT – Research Report) yesterday and set a price target of $217.00. The company’s shares ...

Sarepta Therapeutics exceeded 2024 net product revenue guidance and reaffirmed its 2025 outlook, partly due to strong growth for Duchenne muscular dystrophy drug Elevidys. The company reported ...